15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Vial Adaptor
FDA UDI
WEST PHARMA. SERVICES IL, . LTD·07290108240733·Vial Adapter 20mm FLL w25 mic m Filter – VF
PMMA disc
FDA UDI
Dentsply International Inc.·D00180721160·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867413689·SynoJoynt® 1% Sodium Hyaluronate
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022334·
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 13, 2023
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
Crescendo Meniscal Insert CR Standard 12mm Size 6
FDA UDI
AMPLITUDE SAS·03701089524360·
CANNULATED PARTIALLY THREADED RECONSTRUCTIVE SCREW
FDA Adverse Event
Injury
·BIOMET·Product code HSB·March 13, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT·Product code MCX·April 28, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
STERRAD® NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 20, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012